Optical spectroscopic device for the identification of cervical cancer

ABSTRACT

A medical examination device used for the detection of pre-cancerous and cancerous tissue has an illumination source, a visualization unit, a contacting optical probe, a detector and a process unit. One embodiment of the apparatus includes both a non-contacting macroscopic viewing device (the visualization unit) for visualizing an interior surface of the cervix, as well as a fiber optic wand (contacting optical probe) for spectrally analyzing a microscopic view of the tissue.

CROSS-REFERENCE TO RELATED APPLICATION

The present application, pursuant to 35 U.S.C. 111(b), claims thebenefit of the earlier filing date of provisional application Ser. No.60/966,382 filed Aug. 27, 2007, and entitled “Medical ExaminationDevice” and provisional application Ser. No. 60/999,095 filed Oct. 16,2007, and entitled “Apparatus for Optical Spectroscopic Identificationof Cancer in Clinical Use.”

BACKGROUND OF THE INVENTION

1. Field of the Invention

The invention relates to a medical device for use in a clinicalenvironment that utilizes optical spectroscopic means for theidentification of cervical pre-cancerous and cancerous conditions. Moreparticularly, the present invention relates to a medical examinationapparatus having an illumination source, an optical probe, avisualization unit, a detector, and a processing unit for identifyingpre-cancerous and cancerous conditions.

2. Description of the Related Art

Cervical cancer is the second most common malignancy in women worldwide.The mortality associated with cervical cancer can be reduced if thisdisease is detected at the early stages of development or at thepre-cancerous state. A pap smear is used to screen the general femalepopulation for cervical cancer with more than 70 million performed eachyear in the United States. In spite of its broad acceptance as ascreening test for cervical cancer, pap smears probably fail to detect50-80% 0f low grade cancerous lesions and about 15-30% of high gradelesions.

While the pap smear is designed for initial screening, colposcopy andrelated procedures are typically used to confirm pap smear abnormalitiesand to grade cancerous and potential cancerous lesions. Although it isgenerally recognized that colposcopy is highly effective in evaluatingpatients with abnormal pap smears, colposcopy has its own limitations.Conventional colposcopy is a subjective assessment based on the visualobservation of the clinician and the quality of the results dependsgreatly on the expertise of the practitioner.

Commercially available colposcopes are large free-standing instrumentsand are generally maintained in a single location (i.e., one examinationroom). Furthermore, colposcopes are expensive and are typically sharedby multiple doctors. Accordingly, when a colposcopic examination isrequired, the patient has to be brought to the colposcope. Based on thelimited availability of the colposcope, a special appointment timeseparate from the initial appointment is usually required resulting inadditional time and cost to a patient as well as delayed examinations.

Accordingly, a portable apparatus, which allows for a close-up visualmedical examination would be advantageous for providing an examinationwithout relocation of the patient or providing a separate appointmenttime. Such an apparatus should be readily useable and economical,thereby making diagnosis and treatment more readily available and costefficient.

SUMMARY OF THE INVENTION

One embodiment of the invention provides a medical examination deviceused for the detection of pre-cancerous and cancerous tissue having anillumination source, a visualization unit, a contacting optical probe, adetector and a process unit. A preferred embodiment of the apparatusincludes both a non-contacting macroscopic viewing device (thevisualization unit) for visualizing the cervix, as well as a fiber opticwand (contacting optical probe) for spectrally analyzing a microscopicview of the tissue.

A second embodiment of the invention is a medical examination devicecomprising: an illumination source, wherein the illumination sourceincludes a lamp and a light directing device for selectably directing abeam of light from the lamp in a first direction or in a seconddirection; a visualization unit that receives the beam of light directedin the first direction from the illumination source and radiates atissue with the received beam of light, the visualization unitvisualizes a macroscopic view of the tissue from the light emanatingfrom the tissue illuminated with the beam of light; a fiber optic probeincluding both an excitation fiber optic strand and a reception fiberoptic strand, wherein the excitation fiber optic strand receives thebeam of light directed in the second direction from the illuminationsource and transmits the received beam of light to radiate the tissue ata site of contact with a distal end of the probe, and wherein thecollection fiber optic strand receives the light emanating from thetissue illuminated with the beam of light from the excitation fiberoptic strand and transmits the light to a detector for spectralanalysis.

Another embodiment of the present invention is a medical examinationdevice comprising: an illumination source, wherein the illuminationsource includes a lamp and a plurality of selectably engaged filters forpreparing a beam of light with a selected wavelength; a light beamdirecting device for directing the beam of light into a first beamposition or a second beam position; a visualization unit that receivesthe beam of light in the first beam position and radiates a tissue withthe received beam of light, the visualization unit further comprising anocular device that visualizes a macroscopic view of the tissue from thelight emanating from the tissue illuminated with the beam of light; afiber optic probe having a shaft, a handle, and a fiber optic bundlehaving a plurality of excitation fiber optic strands and a receptionfiber optic strand, wherein the excitation fiber optic strands receivethe beam of light in the second beam position and transmit the receivedbeam of light to radiate the tissue at a site of contact with a distalend of the probe, and wherein the collection fiber optic strand receivesthe light emanating from the tissue illuminated with the second beam oflight and transmits the light to a detector for spectral analysis.

Yet another embodiment of the present invention is a method of screeningfor cervical cancer using spectral analysis comprising the steps of:illuminating a portion of a cervix with a first beam of light;visualizing a macroscopic view of the cervix from the light emanatingfrom the tissue illuminated with the first beam of light; examining themacroscopic view of the cervix to select a tissue site for furtherinvestigation; placing a distal end of a fiber optic probe in contactwith the selected tissue site while visualizing the macroscopic view ofthe cervix; transmitting a second beam of light though a fiber opticcable to illuminate the selected tissue site with the second beam oflight to generate fluorescence or reflectance light at the selectedtissue site; collecting the generated fluorescence or reflectance light;conducting a spectral analysis of the collected light using aspectrometer; and examining the spectral analysis to determine if theselected tissue site is cancerous.

The foregoing has outlined rather broadly several embodiments of thepresent invention in order that the detailed description of theinvention that follows may be better understood. Additional features andadvantages of the invention will be described hereinafter which form thesubject of the claims of the invention. It should be appreciated bythose skilled in the art that the conception and the specific embodimentdisclosed might be readily utilized as a basis for modifying orredesigning the structures for carrying out the same purposes as theinvention. It should be realized by those skilled in the art that suchequivalent constructions do not depart from the spirit and scope of theinvention as set forth in the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

For a more complete understanding of the present invention, and theadvantages thereof, reference is now made to the following descriptionstaken in conjunction with the accompanying drawings, in which:

FIG. 1 is a schematic view illustrating the basic components of themedical examination device and their interrelationship.

FIG. 2 is a schematic view showing the interrelationship of thecomponents in one embodiment of the device.

FIG. 3 is a schematic view showing the interrelationship of thecomponents of one embodiment of the visualization unit.

FIG. 4 is a schematic view showing the interrelationship of theexcitation and collection fiber optic strands in one embodiment of thefiber optic bundle that traverses the optical probe.

FIG. 5 is an oblique view of the wand from its side on which the on/offswitch is mounted, showing the wand with its disposable sheath removed.

FIG. 6 is a view corresponding to FIG. 6, but with the disposable sheathin position for contact with a patient.

FIG. 7 is a schematic view showing the interrelationship of thecomputer/control and the power supply with the basic components of themedical examination device.

FIG. 8 is a schematic view illustrating the interaction of generalcomponents of the device and several optional accessories.

FIG. 9 is an oblique frontal view of the first embodiment of the device.

FIG. 10 is an oblique rear view of the device of FIG. 1.

FIG. 11 is a frontal view of the user interface of the device when thevisualization unit has been selected for use.

FIG. 12 is a frontal view of the user interface of the device when theoptical probe has been selected for use.

FIG. 13 is a view of the external monitor display when the operator hasselected the “View” mode of operation when the visualization unit hasbeen selected for use.

FIG. 14 shows the external monitor display when the optical probe is inuse and the “View Wand” mode has been selected.

FIG. 15 shows an oblique view of a second embodiment of the medicalexamination device while in use.

FIG. 16 is a side profile view of the device of FIG. 15 in its stowedposition.

FIG. 17 is a rear view of the stowed device of FIG. 15.

FIG. 18 is an oblique view of a third embodiment of the medicalexamination device using the optical probe for data acquisition on apatient.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention relates to an apparatus and method for obtainingdiagnostic evaluations of potential precancerous tissues and canceroustumors on externally exposed body surfaces. Specifically, the apparatusis suitable for the identification of skin cancers, oral cancers andcervical cancers. The configuration of the apparatus may be specificallyarranged depending on the anatomical location of the potential cancer.By way of example, a preferred embodiment of the apparatus for thediagnosis of cervical cancer includes both a non-contacting colposcope(a macroscopic visualization unit) and a contacting fiber optic wand (amicroscopic spectral analysis unit).

A colposcope is a device that provides a magnified view of anilluminated area of the cervix, the vagina or the vulva. Cancer andprecancerous conditions are usually indicated by the differingappearance of tissues, including for example the presence of abnormalvessels and whitening after application of acetic acid. Cancer is alsoindicated by different fluorescence than that of normal tissue.

As illustrated in FIG. 1, the medical examination device has anillumination source 100, a visualization unit 200, an optical probe orfiber optic wand 300, a detector 400, a processing unit 500, and a powersupply 600. These basic components may be implemented in a variety ofembodiments and can be packaged in a number of configurations withoutdeparting from the scope of the invention as set forth in the claims.

I. Basic Components of the Medical Examination Device

The Illumination Source

One of the basic components of the medical examination device is theillumination source 100. The illumination source includes a lamp 105, anemergency shutter 102, optional filters and a light directing device.

One embodiment of the lamp 105 is a Xenon or Mercury arc lamp, whileother embodiments include LEDs (light emitting diodes), a Helium Cadmiumlaser, a halogen lamp, and the like. For example, one embodiment uses aplurality of selectable LEDs. Since LEDs are available that emit avariety of colors or emitted wavelength bands, the use of one or moreLEDs can be used to provide the desired wavelength band of the lightbeam emitted.

The generated light is typically transmitted via a liquid light guideand/or fiber optic cable. The schematic representation of theexamination device shown in FIG. 2 illustrates the light generated fromlamp 105 transmitted via a liquid light guide 104 through an emergencyshutter 102 that can be used to shut off all of the light beingtransmitted to the tissue in case of an emergency.

The illumination source also includes a light directing device thatdirects the light to either the visualization unit 200 or the opticalprobe 300. The medical examination device uses the same illuminationsource to provide the light beam for the visualization unit 200 or theoptical probe 300. The light directing device selectably uses theillumination source for either the visualization unit 200 or the opticalprobe 300. An advantage of using a single illumination source for boththe visualization unit 200 and the optical probe 300 is that the lightbeam from the light source can be selectably conditioned or filtered atone location before the beam is directed to the visualization unit 200or the optical probe 300.

A preferred embodiment of the light directing device can reciprocablydirect the emitted light beam in either a first direction to thevisualization unit 200 or in a second direction to the optical probe300. For example, one such embodiment of the light directing device isillustrated in FIG. 2. This light directing device includes a mirror 120that is rotatable between a 1^(st) mirror position 122 and a 2^(nd)mirror position 124.

The mirror 120 is biased into the 1^(st) mirror position 122. The 1^(st)mirror position 122 is up and allows the light beam to continue in aforward horizontal direction to enter the excitation fibers 310 of thewand fiber bundle 302. The mirror 120 is moved into the 2^(nd) mirrorposition 124 whenever the solenoid 130 is selectably actuated. The2^(nd) mirror position 124 reflects the light upward to the mirror 210in the visualization unit 200 which then reflects the light beam 97 tothe tissue 99 for assessment by the visualization unit 200. Oneadvantage of using the reciprocable mirror as the light directing deviceis that a greater percentage of the light intensity is delivered to thetissue than when the light is directed using a beam splitter or dichroicmirror.

An alternative embodiment of the light directing device is shown in FIG.3. Light from the lamp 105 is transmitted through a fiber optic cable 66through a lens 64 and/or an excitation filter 65 and into a beamsplitter and/or dichroic mirror 122. The beam splitter and/or a dichroicmirror 122 selectably diverts the light into a first forwardly extendinghorizontal path 97 to the tissue 99 for use in the macroscopicvisualization unit 200 or into a second forwardly extending horizontalpath 95 for use by the fiber optic wand 300.

Commonly the generated light is conditioned and/or filtered with opticallenses and filters to obtain the desired wavelength band for the lightbeam used for the medical examination. The light is optionallyconditioned or filtered using either one or more selected lenses orfilters, or one or more actuated filter wheels containing a number offilters. If the light beam is to be conditioned using a lens and/or afilter, the lens or filter is typically positioned between the lamp 105emitting the light beam and the light directing device.

The embodiment illustrated in FIG. 2 uses both a motor actuatedconditioning filter wheel 110 and a motor actuated excitation filterwheel 112 to prepare the light used to illuminate the tissue 99. Thesefilter wheels may contain any number of filters and/or lenses, such as apolarizer or neutral density filter or fluorescent filter.Alternatively, the light may be conditioned or filtered using one ormore individual lenses or filters, such as lens 64 and filter 65illustrated in FIG. 3.

Fluorescent and/or reflectance spectra are typically used tocharacterize the pre-cancerous or cancerous condition of the tissuebeing examined. One or more excitation fluorescence bandwidths may beused, such as 455-465 nm, 410-430 nm, 375-385 nm and/or 340-360 nm, toexcite the tissue. Similarly if reflectance is used to examine thetissue, then white light (400-700 nm), or narrower bands such as 455-465nm, 410-430 nm or 550-590 nm may be used to illuminate the tissue.Parallel and/or cross-polarized light may also be used to enhancedifferent tissue structures.

The Visualization Unit

The visualization unit 200 provides a wide field macroscopic view of thetissue 99. The visualization unit 200 is a non-contacting viewer of thetissue 99 and includes an ocular viewer, like a colposcope, and isreferred to herein as the colposcope mode. The visualization unit 200may optionally include a camera 230. Preferred embodiments willtypically include a binocular viewer 250 and an electronic digitalcamera 230 for displaying, capturing and storing reflectance andfluorescence images of the illuminated tissue 99.

One embodiment of the visualization unit 200 shown in FIG. 2 directs alight beam 97 to the tissue sample 99. The beam of light 98 resultingfrom the light beam 97 impinging on the tissue sample 99 is optionallyfiltered or conditioned before being directed to a binocular viewer 250or to a camera 230 for recording. The embodiment illustrated in FIG. 2uses a motor actuated filter wheel 220 to filter or condition the beamof light 98 before sending it through a beam splitter 128 that splitsthe light beam 98 so that the image of the tissue can be seen throughboth the binocular viewer 250 and the camera 230. Alternatively, a lightdirecting device that directs the light beam 98 to either the binocularviewer 98 or the camera 230 may also be used.

The nature of the light beam 98 will depend on the nature of theimpinging light beam 97. For example, if the light beam 97 is whitelight, then the returning light beam 98 is reflected light.Alternatively, if the light beam 97 is fluorescent light that impingeson the surface of the tissue 99 causing it to fluoresce, then the lightbeam 98 will be the resultant fluorescence from the tissue 99.

A second embodiment of the visualization unit 200 is illustrated in FIG.3. The fluorescence or reflected light from the tissue 99 is returned ina beam 98 to the visualization unit 200. This embodiment of thevisualization unit 200 passes the light beam 98 through a beam splitter128, and then optionally conditions or filters the beam 98 using one ormore preselected lenses or filters. For example, the beam splitter 128is shown splitting the light beam 98 through a lens/filter 127 to bevisually displayed to a monocular device 240 and through a lens/filter123 to be photographed by a camera 230.

Alternatively, the same location on the sample may be viewedsimultaneously through the ocular viewer 240 and the camera 230 byremoving the beam splitter 128 and independently adjusting the optics ofthe camera 230 and the ocular device 240.

The Fiber Optic Wand

The fiber optic wand or probe 300 provides a microscopic view of aspecific site on the tissue 99. The fiber optic wand 300 is a contactingoptical probe that delivers a light beam 95 to the tissue 99 via anarray of multiple fiber optic excitation strands or fibers 310 andcollects the emanated light 95 from the tissue with one or more fiberoptic collection strands or fibers 312.

An oblique view of the optical probe 300 is shown in FIGS. 5 and 6. Theprobe has a shaft 370 with a transverse distal end 310 for placing on atissue site 99 to be examined. The probe handle 380 is on an opposedproximal end of the probe 300. The embodiment of the wand 300 shown inFIG. 5 has an on/off switch 360 mounted on the handle 380 for selectablyactivating data acquisition by the probe 300.

A continuous bi-directional fiber optic bundle 302 runs through thehandle 380 and the shaft 370 to the transverse distal end 310 of theshaft 370. The fiber optic bundle 302 may be constructed with any numberof excitation 310 and collection fibers 312 in any configuration. Across section of one embodiment of the fiber optic bundle 302 is shownin FIG. 4. In this embodiment, reflected or emitted light is receivedfrom the illuminated tissue 99 by a single centrally positionedreception strand (or collection fiber 312) which is surrounded bycoaxial multiple outer illumination strands (or excitation fibers 310).

The optical probe 300 has an optional disposable sheath 350 forisolating the shaft 370 from the tissue sample, when the wand 300 is tobe used in the clinic. The distal tip 355 of the sheath 350 is used tocontact the tissue specimen of interest. The sheath 350 and/or itsdistal tip 355 is constructed of a material that is non- or minimallylight scattering and transparent to the emitted wavelength band of lightused for the spectrographic investigation and any reflected orfluorescent light passing back into the wand from the tissue 99. Inaddition, the material should generate minimal autofluorescence. Itshould be noted here that when the disposable sheath 350 is positionedon the probe 300 that it is considered a part of the probe and thedistal end 355 of the sheath 350 becomes the distal end of the probe300.

The Detector Unit

The detector unit 400 is used to analyze the collected light emanatingfrom the tissue 99 that is transmitted through the collection orreception strand(s) 312 through fiber optic cable 74. Typically, thedetector unit 400 obtains the spectra of the light beam 96 received fromthe wand 300. The detector unit is primarily a spectrometer 400,although it may include optical components for conditioning andfiltering the spectral data transmitted through the collection fiber(s)312. Such optical components may be a motor actuated collection filterwheel 410 as shown in FIG. 2, or one or more selected individuallens/filter(s) 405 as shown in FIG. 3.

The Processor Unit

The processing unit 500 includes a computer and/or one or morecontrollers (hereinafter referred to as the computer/controller 580).The processing unit 500 is programmed to configure the operatingmechanical and optical components of the medical examination device thatare not manually operated. In addition, the computer/controller 580processes measured and derived data and is able to store and/or transfersuch data.

Typically the medical examination device has a computer that coordinatesthe overall operation of the device and saves patient data, as well asseveral controllers for activating components such as the solenoid 130for moving the mirror 120 or activating the motors for positioning thefilter wheels to align the desired filter/lens into a beam of light.

One embodiment of the computer/controller 580 and its interaction withother components of the medical device system is shown in FIG. 7. Theembodiment shown in FIG. 7 is provided with multiple bidirectionalcommunication ports 10, 60, 61, and 62 to which data lines 72, 71, 70,and 69 are respectively connected. These communication ports may be usedwith a variety of optional accessories such as shown in FIG. 8 whereport 10 is connected to a data storage device 91 through cable 88, port61 is connected to an external display 92 through cable 89, and port 62is connected to an external keyboard 93 through cable 90. An externalcomputer is optionally connected to the computer/controller 580 throughone of the ports such as port 60.

The bidirectional data line 73 from the computer/controller 580 to theuser interface 550 permits the input of instructions to thecomputer/controller 580 and the reporting of status to the user throughthe user interface 550. Furthermore, a data line 68 from thespectrometer 400 to the computer/controller 580 permits data from thespectrometer 400 to be processed by the computer/controller 580 and thenstored.

The Power Supply

The power supply 600 for the medical examination device may either be arechargeable battery pack or supplied through an electrical cord. FIG. 7shows one embodiment of the power supply 600 and its interactions withother components of the medical examination device.

FIG. 7 illustrates the power supply 600 in series with a main powerswitch 610 for the device and an electric power cord 640. The powersupply 600 regulates output voltages and currents for the variouselectrical and electronic components of the overall system of themedical examination device. Power from the power supply 600 is fed tothe visualization unit 200 via power cable 59 a, to the processing unit500 via power cable 59 b, to the detector 400 via the power cable 59 c,to the illumination source 100 via the power cable 59 d, and to the userinterface 550 via the power cable 59 e.

II. First Embodiment of the Medical Examination Device

Referring to FIGS. 9 and 10, a first embodiment 700 of the medicalexamination device is seen in an oblique frontal view and an obliquerear view. The first embodiment of the device 700 includes a viewer unit701, a base unit 710, and a fiber optic wand 300 as interconnectedsubassemblies.

In FIG. 9, the medical examination device 700 is seen from the frontside, which is the side adjacent the patient and where the light beam 97is emitted from the visualization unit 200 and the light beam 98reflected or emitted as fluorescence from the irradiated patient tissueis received. FIG. 10 shows the device 700 from the rear side which isaccessed by the human operator when the apparatus is in use.

The lamp 105 may be located in the base unit 710 or the viewer unit 701,depending on the amount of heat generated by the lamp and the heat'sdissipation by fans, heat sinks, heat pipes, and the like. Too much heatcan adversely affect the life of the lamp 105, as well as theelectronics in the spectrometer 400 and in the computer/controller 580.

The visualization unit 200, as see in the schematic representation ofFIG. 8, is positioned in the viewer unit 701 and is connected to thepower supply 600 located in the base unit 710 by the power cable 59 aand fiber-optic cables 66 and 74.

In this first embodiment 700, the lamp 105 is positioned in thevisualization unit 200. Fiber optic cable 66 transmits light from thelamp 105 through any selected lenses/filters and to the light directingdevice. The beam of light is then directed either in a first directionto the tissue 99 as beam 97, or the beam of light is directed to theexcitation fibers 310 of the wand fiber optic cable 302 and transmittedto the tissue 99 as beam 95.

Reflectance or fluorescence light from the target specimen 99 inresponse to beam 97 is returned in a beam 98 to the viewer unit 701,where it is filtered and visually displayed by binoculars 250 andphotographed by an electronic camera 230. The camera data is transferredto the computer/controller 580, located in the base unit 710, by aninstrument cable (not shown) and images of the tissue 99 from thereturning beam 98 may be seen on an external display screen 92.

When the wand 300 of the device 700 is used, the light from thefiber-optic cable 66 is filtered and then focused into the bidirectionalfiber optic cable 302. Excitation fibers 310 of the fiber optic cable302 transfers that light to the wand 300, where it is emitted in a beam95 upon the target tissue 99.

The light reflected back in a beam 96 from the tissue 99 typically has adifferent spectral content that the incident light, depending on thecharacter of the cells illuminated in the specimen. This reflected lightis transmitted back through the collection fiber(s) 312 of the fiberoptic cable 302 to the spectrometer 400 in the base unit 710. Thespectrometer 400 is in communication with the computer/controller 580,which is typically positioned in the base unit 710. Thecomputer/controller 580 is generally used to analyze the spectral dataobtained from the spectrometer 400 and stored in the data storage device91.

The base unit 710 has a housing 79 which is mounted on a three leg base75. The base 75 has three approximately equispaced horizontal arms, twoof which have nonswiveling fixed casters 76, while the third has aswiveling caster 17 which can be selectably locked.

Extending vertically from the base 75 is a right circular cylindricaltubular mast mount 77. At its upper end, the mast mount 77 is anaperture mounting a mast 78. At the upper end of the mast mount 77 islocated a mast height adjustment and lock 9. The mast height adjustmentand lock 9 consists of a radially inwardly extending screw with anenlarged handle which is manually operated to loosen or tighten the lock9 against the mast 78.

The housing 79 mounted on the base unit 710 is typically a blow-moldedplastic box having a rectangular horizontal cross-section and ahorizontal flat bottom, along with rounded corners. The long horizontaldimension of the housing 79 is oriented with the radially extendinghorizontal leg of the three-leg base 75 upon which it is mounted. Theupper face of the housing 79 slopes slightly downwardly in a radialdirection.

On its vertical rear face adjacent the mast mount 77, the housing 79 hasan inwardly recessed mounting pocket in which are positionedelectrical/electronic connection sockets such as communication ports 10,60, 61, and 62. On its right side near the bottom is another recessedpocket where the electrical power cord 640 enters the housing 79. A mainpower switch is also positioned there. Various other penetrations forelectrical and fiber-optical cables are provided as needed in thehousing 79.

An array of cooling vents 16 is positioned on the rear vertical face ofthe housing 79 to assist in dissipating any excessive heat buildupwithin the housing. If necessary, a fan (not shown) can be providedinside the housing 79 to aid maintaining a suitable operatingtemperature within the housing 79.

An indicator light 12 is shown in FIG. 10 mounted on the upper surfaceof the housing 79. This indicator light 12 is the startup faultindicator which is connected to the computer/controller 580 and isilluminated when the automated startup and checking routine programmedinto the computer/controller 580 experiences a problem.

Planar tray 13 is parallel to and attached to the upper face of thehousing 79 and provides additional working space for writing and thelike, while a through hole in the right side of the tray provides astowage position for the loose stabbing mounting of the wand 300.Additionally, the user interface 550 is mounted either to the upper sideof housing 79 or to the upper side of tray 13.

The base unit 710 contains the electric power cord 640 in series withthe main power switch 610 and a power supply 600. Power from the powersupply 600 is fed to the user interface 550 via power cable 59 e, to thecomputer/controller 580 by cable 59 b, to the spectrometer 400 by cable59 c, to the xenon arc lamp 105 by cable 59 d, and to the viewer unit701 by power cable 59 a.

The computer/controller 580 is programmed to configure the operatingmechanical and optical components of the viewer unit 701 and the baseunit 710 that are not manually operated. In addition, thecomputer/controller 580 processes measured and derived spectral datafrom the spectrometer 400 and then stores, calculates and/or transferssuch data.

The computer/controller 580 has communication ports 10, 60, 61, and 62respectively connected to data lines 72, 71, 70, and 69. A number ofoptional external electronic accessories are useable with theexamination device 700.

The wand 300 has an elongated central small diameter hollow rightcircular cylindrical stainless steel shaft 370 which is coaxial with thebidirectional fiber optic cable 302 and a coaxial rectangularcross-section handle 380 located at the proximal end of the wand 300.Handle 380 mounts a switch 360 on one side for selectably activatingdata acquisition by the device.

The distal end of the shaft 370 is reduced in diameter. A continuousbidirectional coaxial light path is provided by fiber optic cable 302through the handle 380 and the shaft 370 to the transverse distal end310 of the shaft 370. When in clinical use, a close fitting tubulartransparent disposable plastic sheath 350 having a thin transversedistal end 355 is typically interposed over the shaft 370 for sanitaryreasons.

The light used by the wand 300 is transmitted to and from the device 700over the bidirectional fiber optic cable 302. Reflected or emitted lightreceived from the illuminated target tissue 99 is received by a singlecentrally positioned reception fiber 312 and sent to the spectrometer400. The coaxial emission fibers 310 that surround the reception fiber312 send light passed from the viewer unit 701 to the wand 300.

The viewer unit 701 is mounted on top of the extendable mast 78. Theviewer unit 701 in turn supports the wand 300. The viewer unit 701serves a light distribution and capture function for the overallapparatus 700.

The viewer unit 701 has, from its lower end, a tilt and tilt lockadjustment 7 attached to the top end of the extendable mast 78 of thebase unit 710, a fine focus and focus lock adjustment 6, and a housing120 which supports and contains most of the subassemblies and componentsof the viewer unit 701.

The housing 120 of the viewer unit 701 is hollow and made of blow-moldedplastic so that its corners are rounded. The lower portion of housing120 has a rectangular horizontal cross-section which linearly tapersupwardly where it joins an enlarged upper head portion. The upper headportion extends slightly forward and a relatively larger distancerearward. The upper head is tapered so that it widens and gets taller asit extends rearwardly from the front vertical face. A verticallyelongated window 5 is centrally located on the forward vertical face ofthe upper head, while the rearward vertical face has a central recesswhere the binocular 250 viewing unit and its rearwardly horizontallyextending binocular eyepieces are mounted. The housing 120 is pierced inits lower section to admit the power cable 59 a and one or more otherelectrical data cables (not shown) into the interior of housing 120.

The user interface 550 is shown in FIG. 11 and 12. The user interface550 is a relatively simple operator interface device with multipleselector switches, status indicator lights, and a liquid crystal display(LCD) for text or graphic signal messages. The user interface can beeither permanently mounted onto the upper surface of the housing 79 ofthe base unit 710 or made separable so that it is connected to the baseunit 710 by an intermediate cable containing data line 73 and power line59 e.

Referring to FIG. 11, a power button 18 located at the upper right sideof the panel of the device serves as an off/on switch for the userinterface 550, while power indicator 19 is a status light for showingthe power off/on status of the user interface. Just below the powerbutton 18 is the LCD user interface display 20, with a new patientbutton switch 21, a patient completion button switch 22, and a savebutton switch 23 arranged from left to right adjacent the bottom edge ofthe LCD display. Button switches 21, 22, and 23 provide operatorinstructions to the computer/controller 580.

On the left side of the user interface 550 below the new patient buttonswitch 21, a view button switch 24, a display wand button switch 25, anda display image button switch 26 are sequentially downwardly positioned.These operator selectable switches provide operator instructions to thecomputer/controller 580. On the right side of the user interface 550below the patient completion button switch 22, an up button switch 27, aselect/acquire button switch 28, and a down button switch 29 aresequentially downwardly positioned.

The LCD display has several different text or symbolical status displayswhich are programmed to appear in predetermined locations on thedisplay. These symbols are illustrated in FIGS. 11 and 12. Referring toFIG. 11, the upper left corner holds the instrument mode display 30,which in this case indicates the “View” mode associated with use of thevisualization unit 200, or the colposcope mode. The lower left cornerholds the filter settings display 31, showing in this case that the “Rf1 White” filter (i.e., white light reflectance) is in use. The upperright corner of the LCD holds the illumination timer display 32, showing1 minute and 16 seconds. The lower right corner holds a symbolicindicator 34 which indicates that the illumination is on or off.

When the visualization unit 200 is on and the display image 26 ispressed, the macroscopic image of the illuminated area of the cervix isdisplayed through the ocular viewer, the camera, or an external monitordisplay. FIG. 13 illustrates an external monitor display having a liveview 41 of the cervix from the camera. An electronically displayed setof pertinent sample data is displayed around the periphery of the visualimage of the tissue specimen 99 as seen through the binocular 250, thecamera 230, and/or on an optional external monitor display 92. Thedifferent text or symbolic status displays shown on the monitor are alsoshown in FIG. 13. The top left corner gives the patient identifier 39“20070825” and right below the patient identifier is the current filtersetting, in this case Filter 5 or a fluorescent violet light beam forillumination. In the center at the top of the monitor is theillumination timer display and at the top right is the removable memorycapacity indicator 42. At the bottom right hand corner of the monitor isthe firmware revision display 44.

In FIG. 12, the LCD of the user interface 550 is showing a typicaldisplay when the wand 300 and its associated spectroscopic diagnosticprocedures are in use. The instrument mode display 30 shows that thewand 300 has been enabled, while the illumination timer 32 indicates theelapsed time during the wand operation. A wand measurement acquisitionnumber display 54 (“Result”) is shown on the left bottom side of theLCD, while a spectroscopic evaluation result 55 (“01:082”) is shown as anumerical scale assessment index at the right bottom side of the LCD.The complete results of a series of data acquisitions may also be shownas illustrated in FIG. 14.

III. Second Embodiment of the Medical Examination Device

A second embodiment 800 of the medical examination device is seen in usein an oblique side view in FIG. 15, a stowed position side view in FIG.16, and a stowed position frontal view in FIG. 17.

The second embodiment of the examination device 800 consists of a viewerunit 803, a base unit 801, and a wand 300 as interconnected primarysubassemblies. The base unit 801 is functionally similar to base unit710 of the first embodiment 700, although the base unit is repackaged inorder to permit it to stow more compactly and the casters areeliminated. The wand in the device 800 is substantially similar to wandof the first device embodiment 700, except that the wand extends fromthe base unit 801 rather than the viewer unit 803.

The light directing device illustrated in FIG. 2 is easily configured todirect the light to the wand 300 from the base unit 801. The viewer unit803 is also functionally similar to viewer unit 701 of the firstembodiment. One primary difference is that the viewer unit 803 ismounted on an articulated arm 804 with joints which are eitherfrictionally restrained or restrained by a selectably actuated lockingmechanism so that the linkage will remain rigidly in place until theoperator elects to reposition it.

IV. Third Embodiment of the Medical Examination Device

A third, simplified embodiment 900 of the examination device is seen inuse in an oblique side view in FIG. 18. This embodiment is simplified toprovide only a wand 300 for making visual spectroscopic evaluations ofselected tissue sites. Accordingly, the controls and support equipmentare much simpler, permitting their inclusion within a desktop box 901.The desktop box 901 provides a power supply 600, a lamp 105 withlenses/filters, some simplified controls, an electronic digital camera230, means for a liquid crystal display of the reflected light image ofthe tissue specimen 99, and a spectrometer 400 for numericallyevaluating the results. The major difference in the third embodiment 900is that a visualization unit 200 is not provided.

It should be appreciated by those skilled in the art that the conceptionand the specific embodiment disclosed might be readily utilized as abasis for modifying or redesigning the structures for carrying out thesame purposes as the invention. It should be realized by those skilledin the art that such equivalent constructions do not depart from thespirit and scope of the invention as set forth in the appended claims.

1. A medical examination device comprising: an illumination source,wherein the illumination source includes a lamp and a light directingdevice for selectably directing a beam of light from the lamp in a firstdirection or in a second direction; a visualization unit that receivesthe beam of light directed in the first direction from the illuminationsource and radiates a tissue with the received beam of light, thevisualization unit visualizes a macroscopic view of the tissue from thelight emanating from the tissue illuminated with the beam of light; afiber optic probe including both an excitation fiber optic strand and areception fiber optic strand, wherein the excitation fiber optic strandreceives the beam of light directed in the second direction from theillumination source and transmits the received beam of light to radiatethe tissue at a site of contact with a distal end of the probe, andwherein the collection fiber optic strand receives the light emanatingfrom the tissue illuminated with the beam of light from the excitationfiber optic strand and transmits the light to a detector for spectralanalysis.
 2. The medical examination device of claim 1, furthercomprising a filter wheel between the lamp and the light directingdevice.
 3. The medical examination device of claim 1, wherein the lampincludes a plurality of selectable LEDs.
 4. The medical examinationdevice of claim 1, wherein the light directing device includes a mirrorthat is reciprocable between a first mirror position and a second mirrorposition.
 5. The medical examination device of claim 1, wherein thelight directing device includes a beam splitter.
 6. The medicalexamination device of claim 1, wherein the visualization unit includesan occular device for visualizing the macroscopic view of the tissue. 7.The medical examination device of claim 1, wherein the visualizationunit includes a camera for recording the macroscopic view of the tissue.8. The medical examination device of claim 1, wherein the fiber opticprobe has a transverse distal end for contacting the tissue.
 9. Themedical examination device of claim 1, wherein the fiber optic probeincludes a handle, a shaft, and a bi-directional fiber optic bundle withthe reception fiber optic strand centrally positioned and surrounded bymultiple coaxial excitation fiber optic strands.
 10. The medicalexamination device of claim 9, further comprising a disposable sheathfor covering the shaft of the fiber optic probe.
 11. The medicalexamination device of claim 1, wherein the beam of light used to radiatethe tissue for fluorescence excitation has a wavelength band of about455-465 nm, 410-430 nm, 375-385 nm, or 340-360 nm.
 12. The medicalexamination device of claim 1, wherein the beam of light used to radiatethe tissue for reflectance visualization has a wavelength band of about400-700 nm, 455-465 nm, or 410-430 nm.
 13. The medical examinationdevice of claim 12, wherein the beam of light is polarized orunpolarized.
 14. A medical examination device comprising: anillumination source, wherein the illumination source includes a lamp anda plurality of selectably engaged filters for preparing a beam of lightwith a selected wavelength; a light beam directing device for directingthe beam of light into a first beam position or a second beam position;a visualization unit that receives the beam of light in the first beamposition and radiates a tissue with the received beam of light, thevisualization unit further comprising an ocular device that visualizes amacroscopic view of the tissue from the light emanating from the tissueilluminated with the beam of light; a fiber optic probe having a shaft,a handle, and a fiber optic bundle having a plurality of excitationfiber optic strands and a reception fiber optic strand, wherein theexcitation fiber optic strands receive the beam of light in the secondbeam position and transmit the received beam of light to radiate thetissue at a site of contact with a distal end of the probe, and whereinthe collection fiber optic strand receives the light emanating from thetissue illuminated with the second beam of light and transmits the lightto a detector for spectral analysis.
 15. The medical examination deviceof claim 14, wherein the plurality of filters are in a filter wheel. 16.The medical examination device of claim 14, wherein the lamp is aplurality of selectable LEDs, a Xenon arc lamp, a Mercury arc lamp or ahalogen lamp.
 17. The medical examination device of claim 14, whereinthe light directing device includes a mirror that is reciprocablebetween a first mirror position and a second mirror position.
 18. Themedical examination device of claim 14, wherein the light directingdevice includes a beam splitter.
 19. The medical examination device ofclaim 14, wherein the visualization unit includes a camera for recordingthe macroscopic view of the tissue.
 20. The medical examination deviceof claim 14, wherein the fiber optic probe has a transverse distal endfor contacting the tissue.
 21. The medical examination device of claim14, wherein the reception fiber optic strand is centrally positioned andsurrounded by multiple coaxial excitation fiber optic strands.
 22. Themedical examination device of claim 14, further comprising a disposablesheath for covering the shaft of the fiber optic probe.
 23. The medicalexamination device of claim 14, wherein the beam of light used toradiate the tissue for fluorescence excitation has a wavelength band ofabout 455-465 nm, 410-430 nm, 375-385 nm, or 340-360 nm.
 24. The medicalexamination device of claim 14, wherein the beam of light used toradiate the tissue for reflectance visualization has a wavelength bandof about 400-700 nm, 455-465 nm, or 410-430 nm.
 25. The medicalexamination device of claim 24, wherein the beam of light is polarizedor unpolarized.
 26. A method of screening for cervical cancer usingspectral analysis comprising the steps of: illuminating a portion of acervix with a first beam of light; visualizing a macroscopic view of thecervix from the light emanating from the tissue illuminated with thefirst beam of light; examining the macroscopic view of the cervix toselect a tissue site for further investigation; placing a distal end ofa fiber optic probe in contact with the selected tissue site whilevisualizing the macroscopic view of the cervix; transmitting a secondbeam of light though a fiber optic cable to illuminate the selectedtissue site with the second beam of light to generate fluorescence orreflectance light at the selected tissue site; collecting the generatedfluorescence or reflectance light; conducting a spectral analysis of thecollected light using a spectrometer; and examining the spectralanalysis to determine if the selected tissue site is cancerous.
 27. Themedical examination device of claim 26, wherein the first beam of lightused to radiate the tissue for fluorescence excitation has a wavelengthband of about 455-465 nm, 410-430 nm, 375-385 nm, or 340-360 nm.
 28. Themedical examination device of claim 26, wherein the first beam of lightused to radiate the tissue for reflectance visualization has awavelength band of about 400-700 nm, 455-465 nm, or 410-430 nm.
 29. Themedical examination device of claim 28, wherein the beam of light ispolarized or unpolarized.
 30. The medical examination device of claim26, wherein the beam of light used to radiate the tissue forfluorescence excitation has a wavelength band of about 455-465 nm,410-430 nm, 375-385 nm, or 340-360 nm.
 31. The medical examinationdevice of claim 26, wherein the beam of light used to radiate the tissuefor reflectance visualization has a wavelength band of about 400-700 nm,455-465 nm, or 410-430 nm.
 32. The medical examination device of claim31, wherein the beam of light is polarized or unpolarized.